The primary objective is to assess the safety and tolerability of TAB004 as monotherapy and in combination with toripalimab in subjects with selected advanced solid malignancies, including lymphoma, and to evaluate the recommended Phase 2 dose.
Inclusion Criteria
1. Subjects with histologically or cytologically confirmed advanced unresectable or metastatic solid tumor, including lymphoma that have progressed following prior treatment.
2. Measurable disease per RECISTv1.1 and iRECIST, or RECIL 2017 for lymphoma
3. ECOG performance status of 0 or 1 with life expectancy of 3 months in the opinion of the investigator.
Exclusion Criteria
1. Concurrent enrollment in another clinical study, unless it is an observational (non interventional) clinical study or the follow-up period of an interventional study.
2. Any concurrent anti-cancer therapy, such as but not limited to chemotherapy, targeted therapy, radiotherapy, immunotherapy, or biologic therapy.
3. Current or prior use of immunosuppressive medication within 2 weeks prior to the first dose of TAB004, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids not to exceed 10 mg/day of prednisone or equivalent.
Study Requirements
TAB004 and toripalimab will be administered intravenously (IV). A cycle is 21 days (3 weeks) which includes TAB004 as monotherapy or TAB004 and toripalimab as combination therapy being administered on Day 1 of each cycle.
The trial will include a screening period, treatment period, and follow-ups after the end of treatment. The screening period will be 28 days before starting the study drug. This will include physical examination, vital signs, concomitant medications, safety labs, 12-lead ECG, urine/serum pregnancy test, urinalysis, serology panel, CT or MRI scan in patients with solid tumors and/or 18F-FDG-PET-CT in patients with lymphoma, biomarker assays, and assessment of inclusion and exclusion criteria.
